BONE SCREW SELF-TAPPING N/A 00625006540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-10-09 for BONE SCREW SELF-TAPPING N/A 00625006540 manufactured by Zimmer Manufacturing B.v..

Event Text Entries

[123054844] (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[123054845] It as reported that during an initial hip arthroplasty the head of the screw broke during insertion. The screw was removed and another screw was used in its place. No additional patient consequences were reported. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002648920-2018-00733
MDR Report Key7946432
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-10-09
Date of Report2018-12-11
Date of Event2018-09-17
Date Mfgr Received2018-12-11
Device Manufacturer Date2018-01-29
Date Added to Maude2018-10-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER MANUFACTURING B.V.
Manufacturer StreetTURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1
Manufacturer CityMERCEDITA PR 00715
Manufacturer CountryUS
Manufacturer Postal Code00715
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameBONE SCREW SELF-TAPPING
Generic NamePROSTHESIS, HIP
Product CodeNLF
Date Received2018-10-09
Model NumberN/A
Catalog Number00625006540
Lot Number63919182
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER MANUFACTURING B.V.
Manufacturer AddressTURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.